Yanimo Respimat 2.5 microgram/2.5 microgram, inhalation solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Tiotropium; Olodaterol

Dostopno od:

Boehringer Ingelheim International GmbH

Koda artikla:

R03BB; R03BB54

INN (mednarodno ime):

Tiotropium; Olodaterol

Odmerek:

2.5 µg/2.5 microgram(s)

Farmacevtska oblika:

Inhalation solution

Pot uporabe:

Inhalation

Enote v paketu:

1, 2, 3, 8 single packages, each containing 1 inhaler providing 60 puffs

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Izdeluje:

Boehringer Ingelheim Pharma GmbH & Co. KG

Terapevtska skupina:

Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics

Terapevtsko območje:

Anticholinergics; Anticholinergics

Terapevtske indikacije:

It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Status dovoljenje:

Not marketed

Datum dovoljenje:

2015-06-19

Navodilo za uporabo

R1h/IE MT/PI/2
24/05/2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
YANIMO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM, INHALATION SOLUTION
tiotropium/olodaterol
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Yanimo Respimat is and what it is used for
2. What you need to know before you take Yanimo Respimat
3. How to take Yanimo Respimat
4. Possible side effects
5. How to store Yanimo Respimat
6. Contents of the pack and other information
1.
WHAT YANIMO RESPIMAT IS AND WHAT IT IS USED FOR
WHAT YANIMO RESPIMAT IS
Yanimo Respimat contains two active substances called tiotropium and
olodaterol. These belong to a
group of medicines called long-acting bronchodilators. Tiotropium
belongs to the subgroup of
anticholinergics; olodaterol belongs to the subgroup of long acting
beta
2
agonists.
WHAT YANIMO RESPIMAT IS USED FOR
Yanimo Respimat helps adult patients who have chronic obstructive
pulmonary disease (COPD) to
breathe more easily. COPD is a long-term lung disease that causes
shortness of breath and coughing.
The term COPD is associated with the conditions chronic bronchitis and
emphysema.
Yanimo Respimat helps to open your airways and make it easier to get
air in and out of the lungs.
Regular use of Yanimo Respimat can also help you when you have
on-going shortness of breath
rela

Lastnosti izdelka

HealthProductsRegulatoryAuthority
08July2019
CRN008LK9
Page1of16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
YanimoRespimat2.5microgram/2.5microgram,inhalationsolution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Thedelivereddoseis2.5microgramtiotropium(asbromidemonohydrate)and2.5microgramolodaterol(ashydrochloride)
perpuff.
Thedelivereddoseisthedosewhichisavailableforthepatientafterpassingthemouthpiece.
Excipient with known
effect:Thismedicinecontains0.0011mgbenzalkoniumchlorideineachactuation.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Inhalationsolution
Clear,colourless,inhalationsolution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
YanimoRespimatisindicatedasamaintenancebronchodilatortreatmenttorelievesymptomsinadultpatientswithchronic
obstructivepulmonarydisease(COPD).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Themedicinalproductisintendedforinhalationuseonly.ThecartridgecanonlybeinsertedandusedintheRespimatinhaler.
TwopuffsfromtheRespimatinhalercompriseonemedicinaldose.
_Adults_
Therecommendeddoseis5microgramtiotropiumand5microgram
olodaterolgivenastwopuffsfromtheRespimatinhaler
oncedaily,atthesametimeoftheday.
Therecommendeddoseshouldnotbeexceeded.
_Elderly population_
ElderlypatientscanuseYanimoRespimatattherecommendeddose.
_Hepatic impairment and Renal impairment_
YanimoRespimatcontainstiotropiumwhichisapredominantlyrenallyexcreteddrugandolodaterol,whichispredominantly
metabolizedintheliver.
_Hepatic impairment_
Patients�